Statistical, epidemiological, and risk-assessment approaches to evaluating safety of vaccines throughout the life cycle at the Food and Drug Administration

Robert Ball, Dale Horne, Hector Izurieta, Andrea Sutherland, Mark Walderhaug, Henry Hsu

Research output: Contribution to journalReview articlepeer-review

Abstract

The public health community faces increasing demands for improving vaccine safety while simultaneously increasing the number of vaccines available to prevent infectious diseases. The passage of the US Food and Drug Administration (FDA) Amendment Act of 2007 formalized the concept of life-cycle management of the risks and benefits of vaccines, from early clinical development through many years of use in large numbers of people. Harnessing scientific and technologic advances is necessary to improve vaccine-safety evaluation. The Office of Biostatistics and Epidemiology in the Center for Biologics Evaluation and Research is working to improve the FDA's ability to monitor vaccine safety by improving statistical, epidemiologic, and risk-assessment methods, gaining access to new sources of data, and exploring the use of genomics data. In this article we describe the current approaches, new resources, and future directions that the FDA is taking to improve the evaluation of vaccine safety.

Original languageEnglish (US)
Pages (from-to)S31-S38
JournalPediatrics
Volume127
Issue numberSUPPL. 1
DOIs
StatePublished - May 2011

Keywords

  • Epidemiology
  • Immunization
  • Risk assessment
  • Safety
  • Statistics
  • Vaccine

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

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